BioCardia Announces Timing of the Next Data Safety Monitoring Board Meeting for the CardiAMP Cell Therapy in Heart Failure Pivotal Study
23 Maio 2023 - 8:00AM
BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and
cell-derived therapeutics for the treatment of cardiovascular and
pulmonary diseases today announced that the next Data Safety
Monitoring Board (DSMB) meeting for the CardiAMP Cell Therapy Trial
for Heart Failure is scheduled to take place on July 12th. The
Company expects the FDA’s response to its adaptive statistical
analysis plan supplement early to mid-June and anticipates approval
of the plan and completion of all tasks to implement the plan,
including all data monitoring, in advance of the DSMB meeting.
About the CardiAMP Cell Therapy ProgramCardiAMP
Cell Therapy – designated as an FDA Breakthrough Device – uses a
patient’s own (autologous) bone marrow cells delivered to the heart
in a minimally invasive, catheter-based procedure to potentially
stimulate the body’s natural healing response. The CardiAMP Cell
Therapy Heart Failure Trial is the first multicenter clinical trial
of a stem cell therapy to prospectively screen for stem cell
therapeutic potency in order to improve patient outcomes. CardiAMP
Cell Therapy incorporates three proprietary elements not previously
utilized in investigational cardiac cell therapy: a pre-procedural
diagnostic for patient selection, a high target dosage of cells,
and a proprietary delivery system that has been shown to be safer
than other intramyocardial delivery systems and exponentially more
successful in cell retention. The trial is supported by the
Maryland Stem Cell Research Fund and the Centers for Medicare and
Medicaid Services.
About BioCardia®BioCardia, Inc., headquartered
in Sunnyvale, California, is a developer of two biotherapeutic
platforms – the CardiAMP autologous bone marrow derived
mononuclear cell therapy for cardiovascular indications, and the
NK1R+ allogenic bone marrow derived mesenchymal stem cell therapies
for cardiovascular and pulmonary diseases. These platforms
underlie four product candidates, each with the potential to
meaningfully benefit millions of patients. Three of these
investigational therapies are enabled by the Company’s proprietary
biotherapeutic delivery platforms, which the Company also
selectively licenses to other biotherapeutic development firms.
Forward Looking Statements:This press release
contains forward-looking statements that are subject to many risks
and uncertainties. Forward-looking statements include, among other
things, references to the Company’s investigational product
candidates, efforts in ongoing regulatory discussions with the FDA
with respect to the adaptive statistical analysis plan, including
its implementation, and future DSMB meetings. These forward-looking
statements are made as of the date of this press release, and
BioCardia assumes no obligation to update the forward-looking
statements.
We may use terms such as “believes,” “estimates,” “anticipates,”
“expects,” “plans,” “intends,” “may,” “could,” “might,” “will,”
“should,” “approximately” or other words that convey the
uncertainty of future events or outcomes to identify these
forward-looking statements. Although we believe that we have a
reasonable basis for each forward-looking statement contained
herein, we caution you that forward-looking statements are not
guarantees of future performance and that our actual results may
differ materially from the forward-looking statements contained in
this press release. As a result of these factors, we cannot assure
you that the forward-looking statements in this press release will
prove to be accurate. Additional factors that could
materially affect actual results can be found in BioCardia’s Form
10-K filed with the Securities and Exchange Commission on March 29,
2023, under the caption titled “Risk Factors.” BioCardia expressly
disclaims any intent or obligation to update these forward-looking
statements, except as required by law.
Media Contact:Anne Laluc,
MarketingEmail: alaluc@biocardia.comPhone: 650-226-0120
Investor Contact:David McClung, Chief Financial
OfficerEmail: investors@biocardia.comPhone: 650-226-0120
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